FDA WARNING_LETTER - Grayson Corporation - June 13, 2023

On May 25, 2023, the FDA issued a Warning Letter to Donald Ryan and John Ryan of 14044 W. Petronella Drive Unit #4, Libertyville, IL 60048, following a review of their website, https://www.graysoncorporation.shop. The FDA determined that nicotine pouch products, specifically "2ONE Nicotine Pouches – Mocha Java," were offered for sale and sold to customers in the United States.

The FDA cited a violation under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), stating that the "2ONE Nicotine Pouches – Mocha Java" product is misbranded because it was sold to an individual under 21 years of age. This violates section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)), which prohibits retailers from selling tobacco products to persons younger than 21. The letter clarifies that as of April 14, 2022, the definition of "tobacco product" under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) includes products containing nicotine from any source.